Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202407826889857 Date of Registration: 22/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Immediate Implant Placement Using Tunneling Technique with Connective Tissue Graft versus Coated and Non-Coated DuraGen Matrix with Concentrated Growth Factors
Official scientific title Immediate Implant Placement Using Tunneling Technique with Connective Tissue Graft versus Coated and Non-Coated DuraGen Matrix with Concentrated Growth Factors
Brief summary describing the background and objectives of the trial Mid-facial recession has become a concern following immediate implant placement (IIP), it is now evident that labial bone contour cannot be maintained by placing implants in fresh extraction sockets. Dimensional changes, including the loss of labial soft tissues and mid-buccal mucosal recessions, seem to be expected following immediate placement. Several protocols have been advocated to minimize the possible esthetic impact of the post-extraction remodeling of the bundle bone. These include a correct 3dimensional implant position, a flapless approach, the use of an immediate implant-supported provisional restoration and filling the osseous gap with different biomaterials or thickening the mucosal compartment through soft tissue grafts. Consequently, due to lack of studies aboutthe effect of duragen collagen matrix in soft tissue augmentation around immediate implant placement in esthetic zone and based on the null hypothesis. The present randomized clinical trial will be conducted to evaluate whether this innovative soft tissue augmentation technique using duragen xenogenic collagen matrix alone or when enhanced with CGF versus SCTG has a better impact.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 28/02/2022
Actual trial start date 28/02/2022
Anticipated date of last follow up 31/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL N/A
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Duragen collagen matrix N/A Once at the start of surgical treatment Duragen collagen matrix was applied according to size of periimplant mucosa width Atraumatic extraction of unrestored tooth and place immediate implant using surgical guide then prepare envelope or pouch in attached gingiva around implant and fix collagen matrix 8
Experimental Group Coated Duragen collagen matrix N/A Once at the start of surgical treatment Coated Duragen collagen matrix was applied according to size of periimplant mucosa width coated with injectable CGF Atraumatic extraction of unrestored tooth and place immediate implant using surgical guide then prepare envelope or pouch in attached gingiva around implant and fix with coated collagen matrix with CGF 8
Control Group Subepithelial Connective tissue Graft N/A Once at the start of surgical treatment Subepithelial Connective tissue Graft was applied according to size of periimplant mucosa width Atraumatic extraction of remaining unrestored tooth and place immediate implant using surgical guide then prepare envelope or pouch in attached gingiva around implant and fix the harvested Graft 8 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients in good health with absence of relevant medical condition that contraindicate implant placement e.g. uncontrolled diabetes mellitus or blood coagulation disorder. - Optimal compliance as evidenced by no missed treatment. appointments and a positive attitude toward oral hygiene. - Full mouth plaque score and bleeding on probing < 20% . - Extraction socket type I with adequate native/apical bone to achieve primary implant stability and intact buccal plate of bone. - Thin mucosal phenotype less than 2mm. - Probing depth and clinical attachment level > 3 mm at mid-buccal aspect of failing tooth. - Soft tissue level is at the same level of the contralateral tooth. - Presence of adjacent and opposing dentition. - Presence of enough mesiodistal and interocclusal space for non-occluding provisional restoration. - History of cancer or head and neck radiation. - Extraction socket type II or type III. - Patients with parafunctional occlusal habits as bruxism and clenching that produce overload on the implant. - History of periodontal surgeries or presence of acute infection in the area planned for surgery. - Pregnant females. - Smoking > 10 cigarettes per day. Adult: 19 Year-44 Year 25 Year(s) 55 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/02/2022 Research Ethics Committee Faculty of Dentistry Tanta University
Ethics Committee Address
Street address City Postal code Country
El Gash street Medical Campus Tanta 31773 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Facial Bone Thickness After one year postoperative
Primary Outcome Facial Soft Tissue Thickness After one year postoperative
Primary Outcome Keratinized Mucosal Width After one year postoperative
Secondary Outcome Pink Ethestic Score At crown insertion and at six months postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinical of Oral Medicine Periodontology Oral Diagnosis and Radiology Department Faculty of Dentistry Tanta University El Gash street Medical Campus Tanta 31773 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sara Mohammed Ahmed Sagha El Gash street Medical Campus Tanta 31773 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oral Medicine Periodontology Oral Diagnosis and Radiology Department Faculty of Dentistry Tanta University El Gash street Medical Campus Tanta 31773 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Lubna Abd ElMenaem ElGamal El Gash street Medical Campus Tanta 31773 Egypt
Sahar Fawzy Ghoraba El Gash street Medical Campus Tanta 31773 Egypt
Ahmed Mohammed Badr El Gash street Medical Campus Tanta 31773 Egypt
Sara Mohammed Ahmed Sagha El Gash street Medical Campus Tanta 31773 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lubna ElGamal lobna.elgamal@dent.tanta.edu.eg 00201227722672 El Gash street Medical Campus
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Professor of Oral Medicine Periodontology Oral Diagnosis and Radiology Department Faculty of Dentistry Tanta University
Role Name Email Phone Street address
Scientific Enquiries Sahar Ghoraba sahr.gharabah@dent.tanta.edu.eg 00201111201340 El Gash street Medical Campus
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Professor of Oral Medicine Periodontology Oral Diagnosis and Radiology Department Faculty of Dentistry Tanta University
Role Name Email Phone Street address
Scientific Enquiries Sara Sagha sara_sagha@dent.tanta.edu.eg 00201096516766 El Gash street Medical Campus
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Assistant Lecturer at Oral Medicine Periodontology Oral Diagnosis and Radiology Department Faculty of Dentistry Tanta University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available: Immediately following publication with no end date. For anyone who wishes to access the data For any type (purpose) of analyses Upon proposal(s) that should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol 1 year Proposals should be directed to elsayedamr@yahoo.com Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information